Monthly medicines update

Summary of new marketing authorisations and changes to existing authorisations that relate to the safe use of the product

A rolling 6 month summary with the most recent one first.


Our Product Information Database (PID) is your primary resource for the most current information about all veterinary medicines authorised in Great Britain and Northern Ireland. As product details change we update the Summary of Product Characteristics (SPC) and label text there. Please note there may be a delay before formal documentation is available for some Northern Ireland products. 

It may take up to 12 months for changes to appear on marketed packaging. 


Products are authorised separately in Great Britain and Northern Ireland although authorisations may be aligned if they are the same product held by the same authorisation holder. This may mean that products are authorised or changed on different timescales in each territory.


Also find here a list of specific Pregnancy Warnings which we update quarterly.

November 2024

Change of distribution category

The following product has a change of distribution category from POM-V to NFA-VPS. 
  • Frontpro Chewable Tablets for Dogs (Range)

    Active substance: Afoxolaner

    Territory / Distribution category: GB NFA-VPS

    Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh 

    Change Category: Contraindications, Special warning

    Summary of change:  

    Change of distribution category from POM-V to NFA-VPS, various relevant changes to the SPCs of these products.  

    Section 4.7: Updated to indicate that the products can be used in breeding, pregnant and lactating female dogs.  However, the safety of the veterinary medicinal product has not been established in breeding males.


    Link to SPC 11mg to follow


    Link to SPC 28mg to follow


    Link to SPC 68mg to follow


    Link to SPC 136mg to follow


  • Lotilaner Elanco Chewable Tablets for Dogs (Range)

    Active substance: Lotilaner

    Territory / Distribution category: GB NFA-VPS

    Authorisation holder: Elanco GmbH

    Change Category: Distribution Category

    Summary of change:  

    Due to a change in distribution category from POM-V to NFA-VPS, various relevant changes were made, as appropriate, to the SPCs of these products.


    Link to SPC 56mg


    Link to SPC 112mg


    Link to SPC 225mg


    Link to SPC 450mg


    Link to SPC 900mg


New Authorisations

  • Cirbloc M Hyo Emulsion for Injection for Pigs

    Active substance: Mycoplasma hyopneumoniae, Porcine circovirus-2

    Territory / Distribution category: NI POM-V

    Authorisation holder: Ceva-Phylaxia Veterinary Biologicals Co. Ltd


    SPC available from EU Union Product Database


  • Nobilis Multriva RT+IBm+ND+EDS Emulsion for Injection for Chickens

    Active substance: Egg drop syndrome virus, Newcastle disease virus, Infectious bronchitis virus, Avian metapneumovirus

    Territory / Distribution category: NI POM-V

    Authorisation holder: Intervet International BV


    SPC available from EU Union Product Database


  • ArthriCox 57 mg Chewable Tablets for Dogs; ArthriCox 227 mg Chewable Tablets for Dogs

    Active substance: Firocoxib

    Territory / Distribution category: NI POM-V

    Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd


    SPCs available from EU Union Product Database


  • Lotimil Plus 56.25 mg/2.11 mg Chewable Tablets (1.4–2.8 kg); Lotimil Plus 112.5 mg/4.22 mg Chewable Tablets (> 2.8–5.5 kg); Lotimil Plus 225 mg/8.44 mg Chewable Tablets (> 5.5–11 kg); Lotimil Plus 450 mg/16.88 mg Chewable Tablets (> 11–22 kg); Lotimil Plus 900 mg/33.75 mg Chewable Tablets (> 22–45 kg)

    Active substance: Lotilaner, Milbemycin Oxime (A3 and A4)

    Territory / Distribution category: GB POM-V

    Authorisation holder: Elanco Europe Ltd


    Link to SPC 1.4 - 2.8 kg


    Link to SPC >2.8 - 5.5 kg


    Link to SPC >5.5 - 11 kg


    Link to SPC >11 -  22 kg


    Link to SPC >22 - 45 kg


  • Meloxaid 5 mg/ml Solution for Injection for Dogs and Cats

    Active substance: Meloxicam

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder: EU Pharmaceuticals Ltd


    Link to GB SPC


    Link to NI SPC


  • Milbemycin Oxime Praziquantel Alfamed II 2.5 mg / 25.0 mg Chewable Tablets for Small Dogs and Puppies; Milbemycin Oxime Praziquantel Alfamed II 12.5 mg / 125.0 mg Chewable Tablets for Dogs; Milbemycin Oxime Praziquantel Alfamed II 25.0 mg / 250.0 mg Chewable Tablets for Large Dogs

    Active substance: Milbemycin Oxime (A3 and A4), Praziquantel

    Territory / Distribution category:  GB POM-V

    Authorisation holder: Alfamed


    Link to SPC 2.5 mg/25mg


    Link to SPC 12.5/125.0mg 


    Link to SPC 25mg/250.0mg


Variations - food producing species

  • Bimprocil 300 mg/ml Suspension for Injection for Cattle Sheep and Pigs

    Active substance: Procaine Benzylpenicillin

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder: Bimeda Animal Health Limited

    Change Category: Contraindications, Special warnings; Adverse reactions; Target species use

    Summary of change:  

    Section 4.4: Updated special warnings relating to the use of the product for treating meningitis, infections of the central nervous system, or intracellular pathogens.  Additional information added relating to bacterial species in which acquired resistance has been reported (see also updated section 5.1).


    Section 4.6: Systemic toxic effects have been observed in young piglets, which are transient but can be potentially lethal, especially at higher doses.


    Section 4.9: Treatment duration 3 to 7 days.  Accordingly, the withdrawal periods in section 4.11 have been updated.


    Link to GB SPC


    Link to NI SPC


  • Bovilis Nasalgen-C Nasal Spray, Lyophilisate and Solvent for Suspension for Cattle

    Active substance: Bovine coronavirus

    Territory / Distribution category: NI POM-V

    Authorisation holder: Intervet International B.V.

    Change Category: Contraindications, Special warnings

    Summary of change:  

    Section 3.7: Indication added to include use during pregnancy.


    SPC available from EU Union Product Database


  • Loxicom 20 mg/ml Solution for Injection for Cattle, Pigs and Horses

    Active substance: Meloxicam

    Territory / Distribution category: GB POM-V

    Authorisation holder: Norbrook Laboratories Limited

    Change Category: Contraindications, Special warnings; Adverse reactions

    Summary of change:  

    Section 4.5: This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.


    Section 4.6: In cattle, only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.


    Link to SPC


  • Procactive 300 mg/ml Suspension for Injection for Cattle, Sheep and Pigs

    Active substance: Procaine Benzylpenicillin

    Territory / Distribution category: NI POM-V

    Authorisation holder: Laboratorios SYVA S.A.U

    Change Category: Target species use; Contraindications, Special warnings; Adverse reactions

    Summary of change: 

    Sections 4.1, 4.2 and 4.5: Amended to remove the restriction of the use in pigs weighing 25 kgs or less.


    Section 4.4: Updated special warnings relating to the use of the product for treating meningitis, infections of the central nervous system, or intracellular pathogens.  Additional information added relating to bacterial species in which acquired resistance has been reported (see also updated section 5.1).


    Section 4.6: Systemic toxic effects have been observed in young piglets, which are transient but can be potentially lethal, especially at higher doses.


    Section 4.9: Treatment duration 3 to 7 days.  Accordingly, the withdrawal periods in section 4.11 have been updated.


    Link to SPC


  • Vetimec 5 mg/ml Pour-on Solution for Cattle

    Active substance: Ivermectin

    Territory / Distribution category: GB & NI POM-VPS

    Authorisation holder: Eco Animal Health Ltd

    Change Category: Contraindications, Special warnings

    Summary of change:  

    Section 4.5: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves and protective clothing should be worn when handling the veterinary medicinal product by women of childbearing age.


    Section 4.7: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.


    Link to GB SPC


    Link to NI SPC


Variations - Companion animal species

  • Bimprocil 300 mg/ml Suspension for Injection for Cattle Sheep and Pigs

    Active substance: Procaine Benzylpenicillin

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder: Bimeda Animal Health Limited

    Change Category: Contraindications, Special warnings; Adverse reactions; Target species use

    Summary of change:  

    Section 4.4: Updated special warnings relating to the use of the product for treating meningitis, infections of the central nervous system, or intracellular pathogens.  Additional information added relating to bacterial species in which acquired resistance has been reported (see also updated section 5.1).


    Section 4.6: Systemic toxic effects have been observed in young piglets, which are transient but can be potentially lethal, especially at higher doses.


    Section 4.9: Treatment duration 3 to 7 days.  Accordingly, the withdrawal periods in section 4.11 have been updated.


    Link to GB SPC


    Link to NI SPC


  • Bovilis Nasalgen-C Nasal Spray, Lyophilisate and Solvent for Suspension for Cattle

    Active substance: Bovine coronavirus

    Territory / Distribution category: NI POM-V

    Authorisation holder: Intervet International B.V.

    Change Category: Contraindications, Special warnings

    Summary of change:  

    Section 3.7: Indication added to include use during pregnancy.


    SPC available from EU Union Product Database


  • Loxicom 20 mg/ml Solution for Injection for Cattle, Pigs and Horses

    Active substance: Meloxicam

    Territory / Distribution category: GB POM-V

    Authorisation holder: Norbrook Laboratories Limited

    Change Category: Contraindications, Special warnings; Adverse reactions

    Summary of change:  

    Section 4.5: This product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.


    Section 4.6: In cattle, only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.


    Link to SPC


  • Procactive 300 mg/ml Suspension for Injection for Cattle, Sheep and Pigs

    Active substance: Procaine Benzylpenicillin

    Territory / Distribution category: NI POM-V

    Authorisation holder: Laboratorios SYVA S.A.U

    Change Category: Target species use; Contraindications, Special warnings; Adverse reactions

    Summary of change: 

    Sections 4.1, 4.2 and 4.5: Amended to remove the restriction of the use in pigs weighing 25 kgs or less.


    Section 4.4: Updated special warnings relating to the use of the product for treating meningitis, infections of the central nervous system, or intracellular pathogens.  Additional information added relating to bacterial species in which acquired resistance has been reported (see also updated section 5.1).


    Section 4.6: Systemic toxic effects have been observed in young piglets, which are transient but can be potentially lethal, especially at higher doses.


    Section 4.9: Treatment duration 3 to 7 days.  Accordingly, the withdrawal periods in section 4.11 have been updated.


    Link to SPC


  • Vetimec 5 mg/ml Pour-on Solution for Cattle

    Active substance: Ivermectin

    Territory / Distribution category: GB & NI POM-VPS

    Authorisation holder: Eco Animal Health Ltd

    Change Category: Contraindications, Special warnings

    Summary of change:  

    Section 4.5: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves and protective clothing should be worn when handling the veterinary medicinal product by women of childbearing age.


    Section 4.7: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.


    Link to GB SPC


    Link to NI SPC


October 2024

New Authorisations

  • DIVENCE IBR MARKER LIVE Lyophilisate and Solvent for Emulsion for Injection

    Active substance: Infectious bovine rhinotracheitis virus

    Territory / Distribution category: GB POM-V

    Authorisation holder:  Laboratorios Hipra SA


    Link to SPC




  • DIVENCE PENTA Lyophilisate and Solvent for Emulsion for Injection

    Active substance: Bovine respiratory syncytial virus, Infectious bovine rhinotracheitis virus, Bovine parainfluenza virus 3, E2 recombinant protein, E2 recombinant protein

    Territory / Distribution category: GB POM-V

    Authorisation holder: Laboratorios Hipra SA


    Link to SPC


  • Gamrozyne 150 mg/ml Solution for Injection for Cattle, Sheep and Pigs

    Active substance: Gamithromycin

    Territory / Distribution category:  GB & NI POM-V

    Authorisation holder: Bimeda Animal Health Limited


    Link to GB SPC


    Link to NI SPC


  • Audolyn Ear Drops and Cutaneous Suspension for Cats and Dogs

    Active substance: Miconazole nitrate, Polymyxin B sulphate, Prednisolone acetate

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder: EU Pharmaceuticals Ltd


    Link to GB SPC


    Link to NI SPC


  • Beaphar Insecticidal Shampoo for Dogs, 10mg/g

    Active substance: Permethrin (Cis:Trans 40:60)

    Territory / Distribution category: GB & NI AVM-GSL

    Authorisation holder: Pets Choice Limited


    Link to GB SPC


    Link to NI SPC


  • Earolan Ear Drops and Cutaneous Suspension for Cats and Dogs

    Active substance: Prednisolone acetate, Miconazole nitrate, Polymyxin B sulphate

    Territory / Distribution category:  GB & NI POM-V

    Authorisation holder: EU Pharmaceuticals Ltd


    Link to GB SPC


    Link to NI SPC


  • Otisur Ear Drops and Cutaneous Suspension for Cats and Dogs

    Active substance: Prednisolone acetate, Polymyxin B sulphate, Miconazole nitrate

    Territory / Distribution category:  GB & NI POM-V

    Authorisation holder: EU Pharmaceuticals Ltd


    Link to GB SPC


    Link to NI SPC 


  • Refordog 40 mg/200 mg Spot-on Solution for Dogs over 1.5 kg up to 4 kg; Refordog 100 mg/500 mg Spot-on Solution for Dogs over 4 kg up to 10 kg; Refordog 250 mg/1250 mg Spot-on Solution for Dogs over 10 kg up to 25 kg; Refordog 400 mg/2000 mg Spot-on Solution for Dogs over 25 kg up to 40 kg; Refordog 600 mg /3000 mg Spot-on Solution for Dogs over 40 kg up to 60 kg

Variations - food producing species

  • Bovilis Rotavec Corona Emulsion for Injection for Cattle

    Active substance: Bovine coronavirus, Bovine rotavirus, Escherichia coli

    Territory / Distribution category: GB & NI POM-VPS

    Authorisation holder: MSD Animal Health UK Limited

    Change Category: Administration route

    Summary of change:  

    Added subcutaneous route of administration as an additional route and to allow the associated non-mixed use of Bovilis Rotavec Corona and Bovilis Cryptium. 


    Link to GB SPC


    Link to NI SPC


  • Dalmazin, 75 Micrograms/ml, Solution for Injection for Cattle, Buffaloes and Pigs

    Active substance: Cloprostenol

    Territory / Distribution category: GB POM-V

    Authorisation holder: Fatro S.p.A.

    Change Category: Target Species Use

    Summary of change:  

    Section 4.1: Addition of buffaloes (females) as a target species.

    Section 4.2: Cattle and buffalo: Induction and synchronisation of oestrus and ovulation in combination with GnRH or GnRH analogue, with or without progesterone, as part of fixed time artificial insemination (FTAI) protocols.


    Induction of parturition after day 270 of gestation in cattle and within 10-15 days before expected calving in buffaloes.


    Link to SPC


  • Flordofen 300 mg/ml Solution for Injection for Cattle and Pigs

    Active substance: Florfenicol

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder: Dopharma Research B.V. 

    Change Category: Contraindications, Special Warnings

    Summary of change:  

    Section 4.5/3.5: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.


    Section 4.7/3.7: The safety of the veterinary medicinal product has not been established in cattle and pigs during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.  Use only according to the benefit-risk assessment by the responsible veterinarian. 


    Link to GB SPC


    Link to NI SPC


  • PREVEXXION RN+HVT+IBD Concentrate and Solvent for Suspension for Injection [Chickens]

    Active substance: Marek's disease virus,

    Turkey herpesvirus

    Territory / Distribution category: GB POM-V

    Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh 

    Change Category: Administration Route

    Summary of change:  

    Addition of a in ovo as a new route of administration.


    Link to SPC


  • Procactive 300 mg/ml Suspension for Injection for Cattle and Pigs

    Active substance: Procaine Benzylpenicillin

    Territory / Distribution category: GB POM-V

    Authorisation holder: Laboratorios SYVA S.A.U

    Change Category: Contrindications, special warnings; target species use; withdrawal period

    Summary of change:  

    Section 4.4: After absorption, benzylpenicillin poorly penetrates biological membranes (e.g., blood-brain barrier) since it is ionised and poorly lipid soluble. Use of the product for treatment of meningitis or CNS infections due to e.g., Streptococcus suis or Listeria monocytogenes may not be efficacious. Furthermore, benzylpenicillin penetrates mammalian cells poorly and hence this product may have little effect in treating intracellular pathogens e.g., Listeria monocytogenes.


    Elevated MIC values or bi-modal distribution profiles suggesting acquired resistance have been reported for the following bacteria:


    - Glaesserella parasuis, Staphylococcus spp. causing MMA/PPDS, Streptococcus spp. and S. suis in pigs;


    - Fusobacterium necrophorum causing metritis and Mannheimia haemolytica (only in some member states), as well as Bacteroides spp., Staphylococcus chromogenes, Actinobacillus lignieresii and Trueperella pyogenes in cattle.


    Use of the veterinary medicinal product may result in a lack of clinical efficacy when treating infections caused by these bacteria.


    Section 4.9: The treatment duration is 3 to 7 days. The appropriate treatment duration should be chosen based on the clinical needs and individual recovery of the treated animal. 

    Consideration should be given to the accessibility of the target tissue and characteristics of the target pathogen.


    Section 4.11 Withdrawal periods: 

    Pigs: Meat and offal: 6 days for treatment duration 3-5 days, 8 days for treatment duration 6-7 days. 

    Cattle: Meat and offal: 6 days for treatment duration 3-5 days, 8 days for treatment duration 6-7 days.


    Section 5.1: Enterobacterales, Bacteroides fragilis, most Campylobacter spp., Nocardia spp. and Pseudomonas spp. as well as beta-lactamase–producing Staphylococcus spp. are resistant.


    Link to SPC


  • Rispoval 2 / BRSV + Pi3 Lyophilisate and Solvent for Suspension for Injection for Cattle

    Active substance: Bovine parainfluenza virus 3, Bovine respiratory syncytial virus

    Territory / Distribution category: NI POM-V

    Authorisation holder: Zoetis UK Limited

    Change Category: Target species use

    Summary of change:  

    Section 3.2 & 3.9: The introduction of an additional vaccination scheme and claim against BRSV and Pi-3 for calves which have received a booster vaccination of Rispoval 2 at 12 weeks of age following initial vaccination with Rispoval RS at nine days.


    Link to SPC


  • Rispoval RS+PI3 Intranasal nasal spray lyophilisate and solvent for suspension for cattle

    Active substance: Bovine parainfluenza virus 3, Bovine respiratory syncytial virus

    Territory / Distribution category: NI POM-V

    Authorisation holder: Zoetis UK Limited

    Change Category: Target species use

    Summary of change:  

    Section 3.2 & 3.9: The introduction of an additional vaccination scheme and claim against BRSV and Pi-3 for calves which have received a booster vaccination of Rispoval 2 at 12 weeks of age following initial vaccination with Rispoval RS at nine days.


    Link to SPC


  • Suvaxyn PRRS MLV Lyophilisate and Solvent for Suspension for Injection for Pigs

    Active substance: Porcine respiratory and reproductive syndrome virus

    Territory / Distribution category: NI POM-V

    Authorisation holder: Zoetis Belgium 

    Change Category: Contraindications, Special warnings

    Summary of change:  

    Section 4.7: Removal of warning related to the absence of safety data for use of the vaccine during lactation.


    SPC availabel from the EU Union Product Database


Variations - Companion animal species

  • NexGard Combo Spot-on Solution for Cats <2.5 kg; NexGard Combo Spot-on Solution for Cats 2.5-7.5 kg

    Active substance: Eprinomectin, Esafoxolaner, Praziquantel

    Territory / Distribution category: GB POM-V

    Authorisation holder: Boehringer Ingelheim Vetmedica GmbH

    Change Category: Target species use

    Summary of change:  

    Section 4.2: Immediate and persistent tick killing activity against Ixodes hexagonus for one month. Persistent tick killing activity from 7 days to five weeks against Rhipicephalus sanguineus.


    Link to SPC <2.5kg


    Link to SPC 2.5-7.5kg


  • NexGard Combo Spot-on Solution for Cats <2.5 kg; NexGard Combo Spot-on Solution for Cats 2.5-7.5 kg

    Active substance: Eprinomectin, Esafoxolaner, Praziquantel

    Territory / Distribution category: NI POM-V

    Authorisation holder: Boehringer Ingelheim Vetmedica GmbH

    Change Category: Target species use

    Summary of change:  

    Section 3.2: Persistent tick killing activity from 7 days to five weeks after treatment against Rhipicephalus sanguineus. Persistent tick killing activity from 7 days to four weeks after treatment against Ixodes hexagonus.


    SPCs available from the EU Union Product Database


  • StromEase 25 mg/ml Eye Drops, Solution for Dogs and Cats

    Active substance: Acetylcysteine

    Territory / Distribution category: GB POM-V

    Authorisation holder: DOMES PHARMA

    Change Category: Adverse reactions

    Summary of change:  

    Section 4.6: Irritation or inflammation of the eye and/or its adnexa have been reported in very rare cases following use of the medicinal product. In very rare cases, blinking of the eyelids or even transient closure of the eye, eye redness or conjunctival oedema have been reported, particularly in dogs, according to pharmacovigilance data.


    Link to GB SPC


  • Vetoryl 5 mg / 10 mg / 30 mg / 60 mg / 120 mg Hard Capsules for Dogs

    Active substance: Trilostane

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder: Dechra Limited

    Change Category: Target species use; adverse reactions; Interactions and Overdose

    Summary of change:  

    Section 3.6: Reclassification of the adverse event 'weakness' from very rare to rare.


    Section 3.9: A dose adjustment may be necessary if the dog is swapped from Vetoryl hard capsules to Vetoryl chewable tablets, or vice versa, as a strict interchangeability between the two products cannot be assured, as some dogs may respond differently to the change in pharmaceutical form.


    Section 3.10: There were no mortalities following chronic administration at 32 mg/kg to healthy dogs, however mortalities did occur after repeated administration of higher doses (40–67 mg/kg/day) to healthy dogs.


    Link to GB SPC 5mg


    Link to NI SPC 5mg


    Link to GB SPC 10mg


    Link to NI SPC 10mg


    Link to GB SPC 30mg


    Link to NI SPC 30mg


    Link to GB SPC 60mg


    Link to NI SPC 60mg


    Link to GB SPC 120mg


    Link to NI SPC 120mg


  • Johnson's Easy Spot-On Solution Wormer for Cats & Kittens 20mg

    Active substance: Praziquantel

    Territory / Distribution category: UK AVM-GSL

    Authorisation holder: Vetoquinol UK Limited

    Change Category: Contraindications, Special warnings; Adverse reactions

    Summary of change:  

    Section 4.5: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product by women of childbearing age.


    Section 4.6: Cats and kittens: Occasionally a transient local reaction, such as scurf, mild exudation, alopecia (hair loss), scab, erythema (reddening) and pruritus (itching) may be observed at the application site following treatment.


    Section 4.7: The safety of the veterinary medicinal product has not been established in cats during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.  Use only according to the benefit-risk assessment by the responsible veterinarian.


    Link to SPC


September 2024

New Authorisations

  • Bovimox LA 100 mg/ml Solution for Injection for Cattle

    Active substance: Moxidectin

    Territory / Distribution category: GB & NI POM-VPS

    Authorisation holder:  EU Pharmaceuticals Ltd


    Link to GB SPC


    Link to NI SPC 


  • Moxodex LA 100 mg/ml Solution for Injection for Cattle

    Active substance: Moxidectin

    Territory / Distribution category: GB & NI POM-VPS

    Authorisation holder: EU Pharmaceuticals Ltd


    Link to GB SPC


    Link to NI SPC


  • Ridamec LA 100 mg/ml Solution for Injection for Cattle

    Active substance: Moxidectin

    Territory / Distribution category:  GB & NI POM-VPS

    Authorisation holder: EU Pharmaceuticals Ltd


    Link to GB SPC


    Link to NI SPC


  • Chanear Ear Drops and Cutaneous Suspension for Cats and Dogs

    Active substance: Miconazole nitrate, Prednisolone acetate, Polymyxin B sulphate

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder: EU Pharmaceuticals Ltd


    Link to GB SPC


    Link to NI SPC


  • Coxatab 25 mg / 100 mg / 225 mg Chewable Tablets for Dogs

    Active substance: Firocoxib

    Territory / Distribution category: GB POM-V

    Authorisation holder: CP Pharma Handelsgesellschaft mbH


    Link to SPC 25 mg


    Link to SPC 100 mg


    Link to SPC 225mg


  • Marbotis 3mg/ml + 10mg/ml + 1mg/ml Ear Drops, Suspension for Dogs

    Active substance: Dexamethasone, Clotrimazole, Dexamethasone acetate, Marbofloxacin

    Territory / Distribution category:  GB & NI POM-V

    Authorisation holder: Vet-Agro Multi-Trade Company Sp. z o.o.


    Link to GB SPC


    Link to NI SPC


  • YURVAC RHD Emulsion for Injection for Rabbits

    Active substance: Recombinant RHDV2 virus capsid protein

    Territory / Distribution category:  GB POM-V

    Authorisation holder: Laboratorios Hipra SA


    Link to SPC


Variations - food producing species

  • Cydectin 20 mg/ml LA Solution for Injection for Sheep

    Active substance: Moxidectin

    Territory / Distribution category: GB & NI POM-VPS

    Authorisation holder: Zoetis UK Limited

    Change Category: Contraindications, special warnings; adverse reactions

    Summary of change:  

    Section 4.4 (GB) and 3.4 (NI): Psoroptes ovis is an extremely contagious external parasite of sheep and cattle. To ensure complete control, great care must be taken to avoid re-infestation, as mites may be viable for up to 15 days off the animal. It is important that all animals which have been in contact with infected ones are treated with an appropriate product. Contact between treated, infected and untreated herds must be avoided until at least seven days after treatment.

    Resistance to moxidectin has been reported in Psoroptes ovis scab mites in sheep and in cattle. Cases of side-resistance with other macrocyclic lactones (ivermectin and doramectin) have been reported as well. The use of this product should take into account local information about susceptibility of the target parasites, where available.

    Section 4.6 (GB) and 3.6 (NI): There has been a change to the frequency of the adverse event ‘neurological disorder (such as collapse, convulsion, paralysis)’ to ‘very rare’, with a related note added that severe reactions may be fatal. 


    Link to GB SPC


    Link to NI SPC


  • Qualimec 5 mg/ml Pour-on Solution for Cattle

    Active substance: Ivermectin

    Territory / Distribution category: GB & NI POM-VPS

    Authorisation holder: Eco Animal Health Ltd 

    Change Category: Contraindications, special warnings

    Summary of change:  

    Section 4.5: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.  The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves and protective clothing should be worn when handling the veterinary medicinal product by women of childbearing age.

    Section 4.7: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.  Use only according to the benefit/risk assessment by the responsible veterinarian.


    Link to GB SPC


    Link to NI SPC


Variations - Companion animal species

  • Posatex, Ear Drops Suspension for Dogs

    Active substance: Mometasone Furoate, Orbifloxacin, Posaconazole

    Territory / Distribution category: NI POM-V

    Authorisation holder: Intervet International BV

    Change Category: 

    Summary of change:  

    Section 3.9: Posatex is a viscous suspension. The inherent viscosity will result in a reduced delivery volume compared to the fill volume (see section 5.4). Further information on delivery volume in relation to fill volume for each pack size are provided in section 5.4. 


    SPC available from EU Union Product Database


August 2024

New Authorisations

  • Bimacox 2.5 mg/ml Oral Suspension for Lambs and Calves

    Active substance: Diclazuril

    Territory / Distribution category: NI POM-VPS

    Authorisation holder:  Bimeda Animal Health Limited


    Link to SPC


  • Bimacox 2.5 mg/ml Oral Suspension for Sheep and Cattle

    Active substance: Diclazuril

    Territory / Distribution category: GB POM-VPS

    Authorisation holder: Bimeda Animal Health Limited


    Link to SPC


  • Bovilis Cryptium Emulsion for Injection for Cattle

    Active substance: Cryptosporidium parvum

    Territory / Distribution category:  GB POM-V

    Authorisation holder: MSD Animal Health UK Limited


    Link to SPC


  • Deltamethrin Virbac 10 mg/ml Pour-on Solution for Cattle and Sheep

    Active substance: Deltamethrin

    Territory / Distribution category: GB POM-VPS

    Authorisation holder: VIRBAC


    Link to SPC


  • DIVENCE IBR MARKER LIVE Lyophilisate and Solvent for Suspension for Injection [Cattle]

    Active substance: Infectious bovine rhinotracheitis virus

    Territory / Distribution category:  NI POM-V

    Authorisation holder: Laboratorios Hipra SA


    Link to SPC to follow


  • Doramax 10 mg/ml Solution for Injection for Cattle and Sheep

    Active substance: Doramectin

    Territory / Distribution category:  GB & NI POM-VPS

    Authorisation holder: C&H Generics Ltd


    Link to GB SPC


    Link to NI SPC


  • DrySeal 2.6 g Intramammary Suspension for Cattle

    Active substance: Bismuth subnitrate

    Territory / Distribution category:  GB POM-V

    Authorisation holder: Elanco GmbH, NI

    Elanco Europe Ltd, GB


    Link to SPC


  • Flunex 50 mg/ml Solution for Injection for Cattle, Pigs and Horses

    Active substance: Flunixin

    Territory / Distribution category: NI POM-V

    Authorisation holder:  Livisto Int'l, S.L.


    Link to SPC

  • Triquest 333 mg/ml + 67 mg/ml Oral Suspension for Horses

    Active substance: Trimethoprim, Sulfadiazine

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder:  Alfasan Nederland B.V.


    Link to GB SPC


    Link to NI SPC


  • Cepfenicol 5 mg/ml Eye Drops, Solution for Dogs and Cats

    Active substance: Chloramphenicol

    Territory / Distribution category: NI POM-V

    Authorisation holder: CP Pharma Handelsgesellschaft mbH


    Link to SPC

  • Cepfenidex 2 mg/ml + 1 mg/ml Eye Drops, Solution for Dogs and Cats

    Active substance: Chloramphenicol, Dexamethasone

    Territory / Distribution category: NI POM-V

    Authorisation holder:  CP Pharma Handelsgesellschaft mbH


    Link to SPC


  • Daxocox 140 mg Tablets for Dogs; Daxocox 200 mg Tablets for Dogs

    Active substance: Enflicoxib

    Territory / Distribution category: NI POM-V

    Authorisation holder: Ecuphar NV


    Link to SPC 140 mg to follow


    Link to SPC 200 mg to follow


  • Fluoxevet 32 mg, Tablets for Dogs

    Active substance: Fluoxetine

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder:  Domes Pharma


    Link to GB SPC


    Link to NI SPC


  • Trilocur 50 mg/ml Oral Suspension for Dogs

    Active substance: Trilostane

    Territory / Distribution category: GB POM-V

    Authorisation holder:  Emdoka bvba


    Link to SPC


  • Trilorale 50 mg/ml Oral Suspension for Dogs

    Active substance: Trilostane

    Territory / Distribution category: GB POM-V

    Authorisation holder:  Axience


    Link to SPC


  • Vetoryl Flavoured 20 mg Tablets for Dogs; Vetoryl Flavoured 30 mg Tablets for Dogs; Vetoryl Flavoured 60 mg Tablets for Dogs; Vetoryl Flavoured 120 mg Tablets for Dogs

    Active substance: Trilostane

    Territory / Distribution category: GB POM-V

    Authorisation holder:  Dechra Regulatory B.V.


    Link to SPC 20 mg


    Link to SPC 30mg


    Link to SPC 60mg


    Link to SPC 120mg

     

Variations - food producing species

  • Dalmazin, 75 Micrograms/ml, Solution for Injection for Cattle, Buffaloes and Pigs

    Active substance: Cloprostenol

    Territory / Distribution category: NI POM-V

    Authorisation holder: Fatro S.p.A.

    Change Category: Target species use

    Summary of change:  

    Section 3.1: Addition of buffaloes (females) as a target species.

    Section 3.2: Cattle and buffalo; Induction and synchronisation of oestrus and ovulation in combination with GnRH or GnRH analogue, with or without progesterone, as part of fixed time artificial insemination (FTAI) protocols.

    Induction of parturition after day 270 of gestation in cattle and within 10-15 days before expected calving in buffaloes.


    Link to SPC


  • Oxtra DD 100 mg/ml Solution for Injection for Cattle, Sheep, Pigs, Horses, Dogs and Cats

    Active substance: Oxytetracycline

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder: Fatro S.p.A.

    Change Category: Target species use

    Summary of change:  

    Section 4.12 (GB) and 3.12 (NI): Change to the withdrawal period for cattle and sheep milk when using the 24-hour dosage regimen: cattle milk 72 hours, sheep milk 120 hours.


    Link to GB SPC


    Link to NI SPC


July 2024

New Authorisations

  • Dorimec 10 mg/ml Solution for Injection for Cattle and Sheep

    Active substance: Doramectin

    Territory / Distribution category: GB & NI POM-VPS

    Authorisation holder:  C&H Generics Ltd


    Link to GB SPC


    Link to NI SPC


  • Gastazole 370 mg/g Oral Paste for Horses

    Active substance: Omeprazole

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder: EU Pharmaceuticals Ltd


    Link to GB SPC


    Link to NI SPC


  • Mastic Seal 2.6 Intramammary Suspension for Cattle

    Active substance: Bismuth subnitrate

    Territory / Distribution category:  NI POM-V

    Authorisation holder: Bioveta, a.s.


    Link to SPC


  • Nobilis Multriva RT+IBm+ND+Gm+REOm Emulsion for Injection for Chickens

    Active substance: Avian metapneumovirus, Infectious bronchitis virus, Newcastle disease virus, Infectious bursal disease virus, Avian reovirus

    Territory / Distribution category: NI POM-V

    Authorisation holder: Intervet International BV


    SPC available on the EU Union Product Database


  • Omepratex 370 mg/g Oral Paste for Horses

    Active substance: Omeprazole

    Territory / Distribution category:  GB & NI POM-V

    Authorisation holder: EU Pharmaceuticals Ltd


    Link to GB SPC


    Link to NI SPC


  • Rokopig Entero Emulsion for Injection [Pigs]

    Active substance: Clostridium perfringens, Porcine rotavirus, Escherichia coli

    Territory / Distribution category:  NI POM-V

    Authorisation holder: Bioveta, a.s.


    Link to SPC


  • Coxatab 57 mg Chewable Tablets for Dogs

    Active substance: Firocoxib

    Territory / Distribution category:  GB POM-V

    Authorisation holder: CP Pharma Handelsgesellschaft mbH


    Link to SPC


  • Fatrobendan 1.25 / 5 / 10 mg, Chewable Tablets for Dogs

    Active substance: Pimobendan

    Territory / Distribution category:NI POM-V

    Authorisation holder:  Fatro S.p.A.


    Link to SPC 1.25 mg


    Link to SPC 5 mg


    Link to SPC 10 mg


  • Milpro Chewy 2.5 mg / 25.0 mg Chewable Tablets for Small Dogs and Puppies; Milpro Chewy 12.5 mg / 125.0 mg Chewable Tablets for Dogs; Milpro Chewy 25.0 mg / 250.0 mg Chewable Tablets for Large Dogs

    Active substance: Milbemycin Oxime (A3 and A4), Praziquantel

    Territory / Distribution category: GB POM-V

    Authorisation holder:  VIRBAC

    Praziquantel


    Link to SPC 2.5 mg / 25.0 mg


    Link to SPC 12.5 mg / 125.0 mg


    Link to SPC 25.0 mg / 250.0 mg


  • Otomicol Ear Drops and Cutaneous Suspension for Dogs, Cats and Guinea Pigs

    Active substance: Miconazole nitrate, Prednisolone acetate, Polymyxin B sulphate

    Territory / Distribution category: NI POM-V

    Authorisation holder: KRKA, d.d., Novo mesto


    Link to SPC

  • Urixine 40 mg/ml Syrup for Dogs

    Active substance: Phenylpropanolamine

    Territory / Distribution category: NI POM-V

    Authorisation holder:  Laboratorios Karizoo S.A


    Link to SPC


  • Vetoryl 20 / 30 / 60 / 120 mg Chewable Tablets for Dogs

    Active substance: Trilostane

    Territory / Distribution category: NI POM-V

    Authorisation holder: Dechra Regulatory B.V.


    Link to SPC 20 mg


    Link to SPC 30 mg


    Link to SPC 60 mg


    Link to SPC 120 mg


Variations - food producing species

  • Cydectin 10% LA Solution for Injection for Cattle

    Active substance: Moxidectin

    Territory / Distribution category: GB & NI POM-VPS

    Authorisation holder: Zoetis UK Limited

    Change Category: Target species use; Contraindications, special warnings; 

    Summary of change; Adverse reactions

    NI SPC Section 3.4 & GB 4.4: Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each individual herd. 


    Care should be taken to avoid the following practices, because they increase the risk of development of resistance and could ultimately result in ineffective therapy: Too frequent and repeated use of anthelmintics from the same class, over an extended period of time; Repeated use for an extended period, particularly when using the same class of substances, increases the risk of resistance development. Within a herd, maintenance of susceptible refugia is essential to reduce that risk. Systematically applied interval-based treatment and treatment of a whole herd should be avoided. Instead, if feasible, only selected individual animals or subgroups should be treated (targeted selective treatment). This should be combined with appropriate husbandry and pasture management measures. Guidance for each specific herd should be sought from the responsible veterinarian. Underdosing which may due to underestimation of body weight, misadministration of the veterinary medicinal product, or lack of calibration of the dosing device (if any). 


    Resistance to moxidectin has been reported in Cooperia spp. and Ostertagia spp. in cattle.  Psoroptes ovis is an extremely contagious external parasite of sheep and cattle. To ensure complete control, great care must be taken to avoid reinfestation, as mites may be viable for up to 15 days off the animal. It is important that all animals which have been in contact with infected ones are treated with an appropriate product. Contact between treated, infected and untreated herds must be avoided until at least seven days after treatment.  Resistance to moxidectin has been reported in Psoroptes ovis scab mites in sheep and in cattle. Cases of side-resistance with other macrocyclic lactones (ivermectin and doramectin) have been reported as well. The use of this product should take into account local information about susceptibility of the target parasites, where available.


    NI SPC Section 3.5 & GB 4.5: To prevent a possible anaphylactic type reaction, do not inject the product intravenously.


    NI SPC Section 3.6 & GB 4.6: Hypersensitivity reaction, Neurological disorder (such as collapse, convulsion, paralysis, blindness) have added to this section in the Very rare category. If a   hypersensitivity reaction occurs, a symptomatic treatment should be applied.  Severe neurological reactions may be fatal. 


    NI SPC Section 3.9 & GB 4.9: Underdosing could result in ineffective use and may favour resistance development. To ensure administration of a correct dosage, body weight should be determined as accurately as possible. If animals are to be treated collectively, reasonably homogeneous groups should be set up, and all animals of a group should be dosed at the rate corresponding to the heaviest one. Accuracy of the dosing device should be thoroughly checked.


    Link to GB SPC


    Link to NI SPC


  • Florfenikel 300 mg/ml Solution for Injection for Cattle and Pigs

    Active substance: Florfenicol

    Territory / Distribution category: NI POM-V

    Authorisation holder: Kela nv

    Change Category: Contraindications, Special warnings

    Summary of change:  

    Section 4.5: The use of this veterinary medicinal product may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms. 


    Section 6.6: The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.


    Link to SPC


  • Flubenmix 5%, 50 mg/g Premix for Medicated Feeding Stuff

    Active substance: Flubendazole

    Territory / Distribution category: GB & NI POM-VPS

    Authorisation holder: Kernfarm B.V.

    Change category: Target species use

    Summary of change:  

    Section 1: Name change to Kernfarm Flubenmix 5%, 50 mg/g Premix for Medicated Feeding Stuff   

    NI SPC Section 3.2 & GB 4.2: The product is registered for the treatment of adult stages of the helminth species, and, in case of Ascaridia galli, all intestinal larval stages (L2, L3 and L4) and adult stages.


    Link to GB SPC


    Link to NI SPC


  • Meflosyl 5% Solution for Injection [Horses]

    Active substance: Flunixin

    Territory / Distribution category: UK POM-V

    Authorisation holder: Zoetis UK Limited 

    Change category: Contraindications, Special warnings

    Summary of change:  

    Section 4.5: Flunixin is toxic to avian scavengers. Do not administer to animals susceptible to enter wild fauna food chain. In case of death or sacrifice of treated animals, ensure that they are not made available to wild fauna.

    Section 4.6: added that in very rare cases allergic reactions (anaphylaxis) may occur after administration of the veterinary medicinal product.


    Link to SPC


  • Mycoflor, 300 mg/ml Solution for Injection for Cattle and Pigs

    Active substance: Florfenicol

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder: SP Veterinaria, S.A. 

    Change category: Contraindications, Special warnings

    Summary of change:  

    Section 4.5: The use of this veterinary medicinal product may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms. 

    Section 6.6: The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.


    Link to GB SPC


    Link to NI SPC


  • Selectan 300 mg/ml Solution for Injection for Cattle and Swine

    Active substance: Florfenicol

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder: Laboratorios Hipra SA

    Change category: Contraindications, Special warnings

    Summary of change:  

    Section 4.5: The use of this veterinary medicinal product may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms. 

    Section 6.6: The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.


    Link to GB SPC


    Link to NI SPC


  • Suiseng Coli / C Suspension for Injection for Pigs; Suiseng Diff/A Suspension for Injection for Pigs

    Active substance: Clostridioides difficile;

    Clostridium perfringens

    Territory / Distribution category: GB POM-V

    Authorisation holder: Laboratorios Hipra SA

    Change category: Target species use; Adverse reactions; Interactions & Overdose

    Summary of change:  

    To add the associated use of Suiseng Coli/C with Suiseng Diff/A. SPC update to sections 4.6 (Suiseng Coli/C), 4.8, 4.9. 6.2, 6.3 and 6.5 (Suiseng Diff/A).


    Link to SPC - Coli/C


    Link to SPC - Diff/A


  • Sureseal 2.6 g Intramammary Suspension for Cattle

    Active substance: Bismuth Subnitrate

    Territory / Distribution category: GB POM-V

    Authorisation holder: Norbrook Laboratories Limited

    Change category: Contraindications, Special warnings; Adverse reactions; Target species use

    Summary of change:  

    Section 4.5: Since the product does not have antimicrobial activity, in order to minimise the risk of acute mastitis due to poor infusion technique and lack of hygiene (see section 4.6), it is crucial to follow the aseptic technique of administration described in section 4.9.

    Section 4.6: Acute mastitis has been reported very rarely after use of this product, primarily due to the poor infusion technique and lack of hygiene. Please refer to sections 4.5 and 4.9 regarding the importance of aseptic technique.

    Section 4.9: Care must be taken not to introduce pathogens into the teat in order to reduce the risk of post-infusion mastitis (aseptic technique).  It is essential that the teat is thoroughly cleaned and disinfected, with surgical spirit or alcohol-impregnated wipes.  The teats should be wiped until the wipes are no longer visibly dirty.  Teats should be allowed to dry prior to infusion.  Infuse aseptically and avoid contamination of the syringe nozzle.  Following infusion it is advisable to use an appropriate teat dip or spray.


    Link to SPC


  • Ubroseal Blue Dry Cow 2.6 g Intramammary Suspension for Cattle

    Active substance: Bismuth Subnitrate

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder: Univet Ltd

    Change category: Target species use; Contraindications, Special warnings; Adverse reactions

    Summary of change:  

    Section 4.2: In cows considered likely to be free of sub-clinical mastitis, the veterinary medicinal product can be used on its own in dry cow management and mastitis control


    Section 4.5: The disinfecting towels provided with the intramammary veterinary medicinal product contain isopropyl alcohol. Wear protective gloves if skin irritation due to isopropyl alcohol is known or suspected. Avoid contact with eyes because isopropyl alcohol can cause eye irritation.


    Section 4.6: adverse event Acute mastitis added in the Very rare category.


    Section 4.9: It is essential that the teat is thoroughly cleaned and disinfected, with surgical spirit or alcohol-impregnated disinfecting towels. The teats should be wiped until the disinfecting towels are no longer visibly dirty. Teats should be allowed to dry prior to infusion. Infuse aseptically and take care to avoid contamination of the syringe nozzle. Following infusion it is advisable to use an appropriate teat dip or spray.


    Link to GB SPC


    Link to NI SPC


Variations -  companion animal species 

  • Fortekor 2.5 mg Tablets for Cats and Dogs; Fortekor Flavour 5 mg Tablets for Cats and Dogs; Fortekor Flavour 20 mg Tablets for Dogs

    Active substance: Benazepril Hydrochloride

    Territory / Distribution category: NI POM-V

    Authorisation holder: Elanco Europe Ltd

    Change category: Adverse reactions

    Summary of change:  

    Section 3.6 for dogs only: Adverse events Diarrhoea, Vomiting, Anorexia and Fatigue added to the Rare category, and Elevated creatinine and Incoordination to the Very Rare.


    Link to SPC 2.5 mg


    Link to SPC 5 mg


    Link to SPC 20 mg


  • Thyronorm 5 mg/ml Oral Solution for Cats

    Active substance: Thiamazole

    Territory / Distribution category: GB POM-V

    Authorisation holder: Norbrook Laboratories Limited

    Change category: Target species use

    Summary of change:  

    Section 4.9: If, for reasons of compliance, once daily dosing is preferable, then this is acceptable, although a 2.5mg dose (=0.5ml of the product) given twice daily may be more efficacious in the short term.


    Link to SPC


  • Vetoryl 20 / 30 / 60 / 120 mg Chewable Tablets for Dogs

    Active substance: Trilostane

    Territory / Distribution category: NI POM-V

    Authorisation holder: Dechra Regulatory B.V

    Summary of change:  

    Change in pharmaceutical form (hard capsule to chewable tablets) and new 20 mg strength available.


    Link to SPC 20 mg


    Link to SPC 30 mg


    Link to SPC 60 mg


    Link to SPC 120 mg


June 2024

New Authorisations

  • Amphen 200 mg/ml Suspension for Use in Drinking Water for Pigs

    Active substance: Florfenicol

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder:  Huvepharma NV


    Link to GB SPC


    Link to NI SPC


  • DIVENCE PENTA Lyophilisate and Solvent for Emulsion for Injection [Cattle]

    Active substance: Infectious bovine rhinotracheitis virus, Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, E2 recombinant protein 

    Territory / Distribution category:  NI POM-V

    Authorisation holder: Laboratorios Hipra SA


    SPC available from EU Union Product Database


  • DIVENCE TETRA Lyophilisate and Solvent for Emulsion for Injection [Cattle]

    Active substance: Bovine respiratory syncytial virus, Bovine parainfluenza virus 3, E2 recombinant protein

    Territory / Distribution category:  NI POM-V

    Authorisation holder: Laboratorios Hipra SA


    SPC available from EU Union Product Database


  • Innovax-ND-H5 Concentrate and Solvent for Suspension for Injection for Chickens

    Active substance: Turkey herpesvirus

    Territory / Distribution category: NI POM-V

    Authorisation holder: Intervet International BV


    SPC available from EU Union Product Database


  • Pyrocam 20 mg/ml Solution for Injection for Cattle, Pigs and Horses

    Active substance: Meloxicam

    Territory / Distribution category:  GB & NI POM-V

    Authorisation holder: Huvepharma NV


    Link to GB SPC


    Link to NI SPC


  • RESPIVAC TRT Lyophilisate for Oculonasal Suspension/Use in Drinking Water for Chickens

    Active substance: Avian metapneumovirus

    Territory / Distribution category:  NI POM-V

    Authorisation holder: Laboratorios Hipra SA


    SPC available from EU Union Product Database

  • Rotacur Emulsion for Injection for Cattle

    Active substance: Bovine rotavirus, Bovine coronavirus, Escherichia coli

    Territory / Distribution category:  GB POM-VPS

    Authorisation holder: Forte Healthcare Limited


    Link to SPC


  • Alcort 0.584 mg/ml Cutaneous Spray, Solution [Dogs]

    Active substance: Hydrocortisone aceponate

    Territory / Distribution category:NI POM-V

    Authorisation holder:  Nextmune Italy S.R.L.


    SPC available from EU Union Product Database

  • Bravecto 150 mg/ml Powder and Solvent for Suspension for Injection for Dogs

    Active substance: Fluralaner

    Territory / Distribution category: GB POM-V

    Authorisation holder:  MSD Animal Health UK Limited


    Link to SPC


  • Eluracat 20 mg/ml Oral Solution for Cats

    Active substance: Capromorelin tartrate

    Territory / Distribution category: GB POM-V

    Authorisation holder: Elanco GmbH


    Link to SPC

  • Meloxicam Ceva 0.5 mg/ml Oral Suspension for Cats; Meloxicam Ceva 1.5 mg/ml Oral Suspension for Dogs; Meloxicam Ceva 5 mg/ml Solution for Injection for Dogs and Cats
  • Milbemycin Oxime Praziquantel Alfamed 2.5 mg / 25.0 mg Chewable Tablets for Small Dogs and Puppies; Milbemycin Oxime Praziquantel Alfamed 12.5 mg / 125.0 mg Chewable Tablets for Dogs

    Active substance: Milbemycin Oxime (A3 and A4), Praziquantel

    Territory / Distribution category: GB & NI POM-V

    Authorisation holder: Alfamed


    Link to GB SPC 2.5mg / 25.0 mg


    Link to NI SPC 2.5mg / 25.0 mg


    Link to GB SPC 12.5mg / 125.0 mg


    Link to NI SPC 12.5mg / 125.0 mg


  • Milbemycin Oxime Praziquantel Chew Alfamed 25.0 mg / 250.0 mg Chewable Tablets for Large Dogs

    Active substance: Milbemycin Oxime (A3 and A4), Praziquantel

    Territory / Distribution category: NI POM-V

    Authorisation holder: Alfamed


    Link to SPC


  • Milpro Chewy 2.5 mg / 25.0 mg Chewable Tablets for Small Dogs and Puppies; Milpro Chewy 12.5 mg / 125.0 mg Chewable Tablets for Dogs; Milpro Chewy 25.0 mg / 250.0 mg Chewable Tablets for Large Dogs

    Active substance: Milbemycin Oxime (A3 and A4), Praziquantel

    Territory / Distribution category: NI POM-V

    Authorisation holder:  VIRBAC


    Link to GB SPC 2.5mg/25.0mg


    Link to NI SPC 2.5mg/25.0mg


    Link to GB SPC 12.5mg/125.0mg


    Link to NI SPC 12.5mg/125.0mg


    Link to GB SPC 25mg/250.0mg


    Link to NI SPC 25mg/250.0mg


  • Otomicol Ear Drops and Cutaneous Suspension for Dogs and Cats

    Active substance: Miconazole Nitrate, Prednisolone Acetate, Polymyxin B Sulphate

    Territory / Distribution category: GB POM-V

    Authorisation holder:  KRKA, d.d., Novo mesto


    Link to SPC


Variations - food producing species

  • Bovilis INtranasal RSP Live, Nasal Spray, Lyophilisate and Solvent for Suspension for Cattle

    Active substance: Bovine parainfluenza virus 3; Bovine respiratory syncytial virus

    Territory / Distribution category: NI POM-V

    Authorisation holder: MSD Animal Health UK Limited

    Summary of change:  

    Introduction of associated non-mixed use with Bovilis Nasalgen-C. 


    Introduction of a claim for use of Bovilis INtranasal RSP Live during pregnancy.


    Link to SPC


  • Nobilis MG 6/85 Lyophilisate for Suspension for Chickens

    Active substance: Mycoplasma gallisepticum

    Territory / Distribution category: GB POM-V

    Authorisation holder: MSD Animal Health UK Limited

    Summary of change:  

    Removal of Nobilis MS Live mixed-use claims and related information. 


    Link to SPC


  • Norocillin 30% w/v Suspension for Injection [Cattle, Pigs, Sheep]

    Active substance: Procaine Benzylpenicillin

    Territory / Distribution category: UK POM-V

    Authorisation holder: Norbrook Laboratories Limited

    Change category: Target species use; Contraindications; Special warnings; Adverse reactions

    Summary of change:  

    Section 4.2: In vitro tests have shown the following organisms to be sensitive:  Trueperella pyogenes.


    Section 4.4: After absorption, benzylpenicillin poorly penetrates biological membranes (e.g., blood-brain barrier) since it is ionised and poorly lipid soluble. Use of the product for treatment of meningitis or CNS infections due to e.g., Streptococcus suis or Listeria monocytogenes may not be efficacious. Furthermore, benzylpenicillin penetrates mammalian cells poorly and hence this product may have little effect in treating intracellular pathogens e.g., Listeria monocytogenes.

    Elevated MIC values or bi-modal distribution profiles suggesting acquired resistance have been reported for the following bacteria:

    - Glaesserella parasuis, Staphylococcus spp. causing MMA/PPDS, Streptococcus spp. and S. suis in pigs;

    - Fusobacterium necrophorum causing metritis and Mannheimia haemolytica, as well as Bacteroides spp., Staphylococcus chromogenes, Actinobacillus lignieresii and Trueperella pyogenes in cattle.

    Use of the veterinary medicinal product may result in a lack of clinical efficacy when treating infections caused by these bacteria.


    Section 4.6: Systemic toxic effects have been observed in young piglets, which are transient but can be potentially lethal, especially at higher doses.


    Section 4.9: The recommended dose rate is: 10 mg/kg bodyweight (1 ml/30 kg) daily for 3 to 7 days.


    Section 5.1: Enterobacterales, Bacteroides fragilis, most Campylobacter spp., Nocardia spp. and Pseudomonas spp. as well as beta-lactamase–producing Staphylococcus spp. are resistant. 


    Link to SPC


  • Porcilis PCV ID Emulsion for Injection for Pigs

    Active substance: Porcine circovirus-2

    Territory / Distribution category: GB POM-V

    Authorisation holder: MSD Animal Health UK Limited

    Change category: Target Species use

    Summary of change:  

    Section 4.2: Duration of the immunity extended from 23 weeks to 26 weeks.


    Link to SPC


  • Ultrapen LA 30% Suspension for Injection [Cattle, Pigs]

    Active substance: Mycoplasma gallisepticum

    Territory / Distribution category: UK POM-V

    Authorisation holder: Norbrook Laboratories Limited 

    Change category: Target Species use, Contradictions; Special warnings; adverse reactions; 

    Summary of change:  

    Section 4.2: Ultrapen LA is indicated for use in cattle and pigs in the treatment and control of a wide range of common systemic, respiratory, urinary and local infections caused by or associated with organisms sensitive to penicillin, including Trueperella pyogenes.


    Section 4.4: After absorption, benzylpenicillin poorly penetrates biological membranes (e.g., blood-brain barrier) since it is ionised and poorly lipid soluble. Use of the product for treatment of meningitis or CNS infections due to e.g., Streptococcus suis or Listeria monocytogenes may not be efficacious. Furthermore, benzylpenicillin penetrates mammalian cells poorly and hence this product may have little effect in treating intracellular pathogens e.g., Listeria monocytogenes.

    Elevated MIC values or bi-modal distribution profiles suggesting acquired resistance have been reported for the following bacteria:

    - Glaesserella parasuis, Staphylococcus spp. causing MMA/PPDS, Streptococcus spp. and S. suis in pigs;

    - Fusobacterium necrophorum causing metritis and Mannheimia haemolytica, as well as Bacteroides spp., Staphylococcus chromogenes, Actinobacillus lignieresii and Trueperella pyogenes in cattle.

    Use of the veterinary medicinal product may result in a lack of clinical efficacy when treating infections caused by these bacteria.


    Section 4.6: Systemic toxic effects have been observed in young piglets, which are transient but can be potentially lethal, especially at higher doses.


    Section 5.1: Enterobacterales, Bacteroides fragilis, most Campylobacter spp., Nocardia spp. and Pseudomonas spp. as well as beta-lactamase–producing Staphylococcus spp. are resistant. 


    Link to SPC


Variations -  companion animal species 

  • Amcofen 12.5 mg/125.0 mg Chewable Tablets for Dogs Weighing at Least 5 kg; Amcofen 2.5 mg/25 mg Chewable Tablets for Small Dogs and Puppies Weighing at Least 0.5 kg

    Active substance: Milbemycin Oxime (A3 and A4); Praziquantel

    Territory / Distribution category: GB POM-V

    Authorisation holder: KRKA, d.d., Novo mesto 

    Change category: Adverse reactions

    Summary of change:  

    Section 4.6: On very rare occasions, hypersensitivity reaction, systemic signs (such as lethargy), neurological signs (such as muscle tremors and ataxia) and/or gastrointestinal signs (such as emesis, diarrhoea, anorexia and drooling) have been observed in dogs after administration of the combination of milbemycin oxime and praziquantel.


    Link to SPC 12.5mg/125.0mg


    Link to SPC 2.5mg/25mg


  • MiPet Benazapet 2.5 mg Tablets for Cats and Dogs; MiPet Benazapet 5 mg Tablets for Cats and Dogs; MiPet Benazapet 20 mg Tablets for Dogs

    Active substance: Benazepril Hydrochloride

    Territory / Distribution category: UK POM-V

    Authorisation holder: Elanco Europe Ltd

    Change category: Adverse reactions

    Summary of change:  

    Section 4.6: In rare occasions diarrhoea and anorexia have been reported in dogs.


    Link to SPC 2.5 mg


    Link to SPC 5 mg


    Link to SPC 20 mg



What do you think about our websites?

Share by: